MALE CIRCUMCISION KITS:RAPIDECLAMP— 510(k) K142163
Substantially EquivalentMedicfit Technology Sdn Bhd
FDA 510(k) clearance K142163 for MALE CIRCUMCISION KITS:RAPIDECLAMP, Substantially Equivalent on 2015-04-20. Applicant: Medicfit Technology Sdn Bhd.
Clearance details
- Applicant
- Medicfit Technology Sdn Bhd
- Product code
- Code HFX
- Advisory panel
- Obstetrics/Gynecology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Great Neck, NY, US
Adverse events under product code HFX
product code HFX- Other
- 3
- Total
- 3
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.